An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression

A study testing rTMS Treatment in people with Depression, run by Mayo Clinic at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this investigation is to examine the safety and feasibility of a series of repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz [Hz]; Left Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant treatment for depression in adolescent subjects. Read more about this study

Who is it for?: Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: rTMS Treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 3 sitesUnited States
Study dates: May 2007to Oct 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of unipolar major depression without psychosis.
Current or past history of lack of response to at least two adequate antidepressant trials selective serotonin re-uptake inhibitors (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF)
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or higher at baseline
At least six weeks of ongoing SSRI therapy at a stable dose.
SSRI Medications will include:
Citalopram (Celexa, Cipramil, Emocal, Sepram)

Show all 14Show fewer

Escitalopram oxalate (Lexapro, Cipralex, Esertia)
Fluoxetine (Prozac, Fontex, Seromex, Seronil, Sarafem, Fluctin (EUR))
Fluvoxamine maleate (Luvox, Faverin)
Paroxetine (Paxil, Seroxat, Aropax, Deroxat)
Sertraline (Zoloft, Lustral, Serlain)
Age 13-18 years.
Outpatient, inpatient, or partial hospitalization patients.
Capable of providing informed assent/consent (in addition to parent/guardian consent).

Who cannot join

Current Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, pervasive developmental disorder, somatoform disorder, dissociative disorder, posttraumatic stress disorder, obsessive-compulsive disorder, eating disorders, antecedents of autism, and all personality disorders.
Active substance dependence (except nicotine) in the past 12 months.
Subjects with a history of head trauma, unprovoked seizure history, seizure disorder, or family history of treatment resistant epilepsy.
Suspected pregnancy or pregnancy as confirmed by a urine pregnancy test at screening.
History of failure to respond to ECT.
Metal in the head (except in the mouth), implanted medication pump, cardiac pacemaker.

Show all 17Show fewer

Prior brain surgery.
Risk for increased intracranial pressure such as brain tumor.
Unable to obtain motor threshold in the subject or motor threshold too high, such that 120% MT cannot be obtained (i.e. >84% of device output).
Significant change or increase in antidepressant medications within the last six weeks.
Change in psychiatrist, psychologist, or therapist within the last four weeks.
Suicide attempt within the past three months.
Any suicide attempt or suicidal intent during the study will terminate involvement in this study.
Subjects currently on stimulant, antipsychotic, atypical antidepressant or tricyclic antidepressant medications.
Unstable medical or neurological conditions that may include hematological, infectious (such as Human immunodeficiency virus [HIV] positive patients) metabolic, or cardiovascular conditions that may preclude safe participation in trial.
Subjects undergoing anticoagulant, immune suppressive and 1 or chemotherapy, or those who received any of these therapies </=3 months before enrollment in the study
Subjects with intra-cardiac lines

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Rush University
Chicago, Illinois, 60612
University of Texas Southwestern
Dallas, Texas, 75390
Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression

Read the detailed description

High frequency rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) has been shown to have an antidepressant effect. Initial studies comparing electroconvulsive therapy (ECT) and rTMS suggest that rTMS has been as effective as ECT in treating non-psychotic depression. Given the high degree of ongoing dysfunction in depressed adolescents despite optimization of treatment with antidepressant medications, new concerns regarding suicidal thoughts and behaviors in adolescents treated with antidepressant medications, and the more interventional nature of ECT, the use of rTMS as adjuvant therapy may be of significant clinical benefit. Thus far, research using rTMS to treat depression in adolescents has been limited. The primary aim of this study is to examine the safety and feasibility of using 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in adolescents.

Conditions: Depression
Being tested: rTMS Treatment
Keywords: Adolescent, Depression, rTMS
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rTMS TreatmentDevice
Also called Neuronetics Model 2100 Therapy System
Active rTMS treatment.

Study groups in NCT00587639
Study group	Role	What they receive
rTMS Treatment	Experimental	All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment) Receives: Device: rTMS Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)
The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.
Measured: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)

Secondary outcomes (1)

Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)
The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60).
Measured: At study visit 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Oct 2009

First posted7 Jan 2008 (estimated)
Study startMay 2007
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00587639
Sponsor's protocol ID: 07-000495
Status last verified: Mar 2012
First submitted: 21 Dec 2007
Last updated: 12 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003.
PubMed 21951987
Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.
PubMed 31634515

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression
ClinicalTrials.gov ID: NCT00587639
Acronym / sponsor ID: 07-000495
Conditions: Depression
Keywords: Adolescent, Depression, rTMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Eli Lilly and Company
Study start: May 2007
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 7 Jan 2008 (estimated)
Results: Posted 9 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
rTMS Treatment	Experimental	Device: rTMS TreatmentAll subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)

Who may qualify

Ages: 13 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (14 listed)

Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of unipolar major depression without psychosis.
Current or past history of lack of response to at least two adequate antidepressant trials selective serotonin re-uptake inhibitors (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF)
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or higher at baseline
At least six weeks of ongoing SSRI therapy at a stable dose.
SSRI Medications will include:

Key exclusion criteria (17 listed)

Current Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, pervasive developmental disorder, somatoform disorder, dissociative disorder, posttraumatic stress disorder, obsessive-compulsive disorder, eating disorders, antecedents of autism, and all personality disorders.
Active substance dependence (except nicotine) in the past 12 months.
Subjects with a history of head trauma, unprovoked seizure history, seizure disorder, or family history of treatment resistant epilepsy.
Suspected pregnancy or pregnancy as confirmed by a urine pregnancy test at screening.
History of failure to respond to ECT.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rTMS TreatmentAlso: Neuronetics Model 2100 Therapy SystemActive rTMS treatment.	Device	rTMS Treatment

Primary outcome

Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)
Time frame: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)
The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.

1 secondary outcome

Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)
Time frame: At study visit 30

Results and safety

Results posted to the registry on 9 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment	8	7

Primary outcome: Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)

Time frame: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit). Mean (Standard Deviation). Unit: units on a scale

Measure	rTMS Treatment n = 7
Value	-11.3 (12.98)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Subjects were assessed for safety over the 6-8 weeks of treatment and at the 6- month follow-up assessment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Limitations and caveats (from the sponsor): Limitations of the study include its open design, and small number of total participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21951987Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003.
Derived from this study: PubMed 31634515Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shirlene M. Sampson, M.D. principal investigator

Mayo Clinic

Christopher A. Wall, M.D. principal investigator

Mayo Clinic

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing rTMS Treatment in people with Depression, run by Mayo Clinic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2) (time frame: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00587639, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.